BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTACK 5MM INSTRUMENT

    MDR report key: 1861935 · Received October 5, 2010

    Report

    Report Number
    2647580-2010-00817
    Event Type
    Injury
    Date Received
    October 5, 2010
    Report Date
    September 10, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    KOG
    PMA / PMN Number
    K963999
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC INCISIONAL HERNIA REPAIR. ACCORDING TO THE REPORTER: NINE DAYS POST-OPERATIVELY, THE PT ALLEGEDLY PRESENTED WITH EXTENSIVE PERICARDIAC TAMPONADE WHICH WAS TREATED WITH ULTRASONICALLY GUIDED PERCUTANEOUS DRAINAGE. STERNOTOMY SHOWED A SPIRAL TACKER PROTRUDING THROUGH THE PERICARDIUM, RESULTING IN A LESION OF 2 X 2 MM IN THE RIGHT VENTRICLE. FIVE SPIRAL TACKERS WERE VISIBLE FROM THE INSIDE OF THE PERICARDIUM AND TWO HAD GONE THROUGH THE DIAPHRAGM AND INTO THE PLEURAL CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTACK 5MM INSTRUMENT DISPOSABLE SURGICAL STAPLER KOG USSC PUERTO RICO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other